Florida Senate - 2006 COMMITTEE AMENDMENT
Bill No. CS for SB 926
Barcode 341664
CHAMBER ACTION
Senate House
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11 The Committee on Judiciary (Villalobos) recommended the
12 following amendment:
13
14 Senate Amendment (with title amendment)
15 Delete everything after the enacting clause
16
17 and insert:
18 Section 1. Subsection (31) of section 499.003, Florida
19 Statutes, is amended to read:
20 499.003 Definitions of terms used in ss.
21 499.001-499.081.--As used in ss. 499.001-499.081, the term:
22 (31) "Pedigree paper" means:
23 (a) A document required pursuant to s. 499.0121(6)(d)
24 or (e); or
25 (b) Effective July 1, 2006, a document or electronic
26 form approved by the Department of Health and containing
27 information that records each distribution of any given legend
28 drug, from sale by a pharmaceutical manufacturer, through
29 acquisition and sale by any wholesaler or repackager, until
30 final sale to a pharmacy or other person administering or
31 dispensing the drug. The information required to be included
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1 on a legend drug's pedigree paper must at least detail the
2 amount of the legend drug; its dosage form and strength; its
3 lot numbers; the name and address of each owner of the legend
4 drug and his or her signature; its shipping information,
5 including the name and address of each person certifying
6 delivery or receipt of the legend drug; an invoice number, a
7 shipping document number, or another number uniquely
8 identifying the transaction; and a certification that the
9 recipient wholesaler has authenticated the pedigree papers. If
10 the manufacturer or repackager has uniquely serialized the
11 individual legend drug unit, that identifier must also be
12 included on the pedigree. It must also include the name,
13 address, telephone number and, if available, e-mail contact
14 information of each wholesaler involved in the chain of the
15 legend drug's custody. The department shall adopt rules and a
16 form relating to the requirements of this paragraph no later
17 than 90 days after the effective date of this act; or.
18 (c) Effective July 1, 2006, a document or electronic
19 form approved by the Department of Health and containing
20 information that records each distribution of any given legend
21 drug, from sale by a pharmaceutical manufacturer, through
22 acquisition and sale by any wholesaler or repackager, until
23 final sale to a pharmacy or other person administering or
24 dispensing the drug; or, if a specific unit of the legend drug
25 was purchased by a wholesaler, referred to in this paragraph
26 as a "direct purchase wholesaler," directly from the
27 manufacturer, an invoice for the specific unit of the legend
28 drug together with a certificate under oath in written or
29 electronic form stating that:
30 1. If the establishment is not a member of an
31 affiliated group: "This establishment purchased the specific
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1 unit of the legend drug directly from the manufacturer."
2 2. If the establishment is a member of an affiliated
3 group: "This establishment or a member of its affiliated group
4 purchased the specific unit of the legend drug directly from
5 the manufacturer."
6
7 A document or electronic form that meets the requirements of
8 this paragraph shall constitute a sufficient pedigree paper
9 only for the purpose of a single sale or distribution
10 transaction in the specific unit of legend drug by the direct
11 purchase wholesaler to an entity authorized by law to purchase
12 legend drugs. For each transaction of the specific unit of
13 legend drug, the direct purchase wholesaler is required to
14 create a separate pedigree paper that meets the requirements
15 of this paragraph and furnish such pedigree paper to any
16 subsequent purchaser. The pedigree paper shall be prepared and
17 updated for every transfer following the direct purchase
18 wholesaler's receipt of the specific unit of legend drug
19 directly from the manufacturer. The information required to be
20 included on the document or electronic form approved by the
21 department pursuant to this paragraph and required of any
22 subsequent transfers of legend drugs received by a direct
23 purchase wholesaler in a transaction described in this
24 paragraph must at least detail the amount of the legend drug;
25 its dosage form and strength; its lot numbers; the name and
26 address of each owner of the legend drug after it has left the
27 possession of the manufacturer and his or her signature; its
28 shipping information, including the name and address of each
29 person certifying delivery or receipt of the legend drug after
30 it has left the possession of the manufacturer; an invoice
31 number, a shipping document number, or another number uniquely
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1 identifying the transaction; and a certification that the
2 recipient direct purchase wholesaler has authenticated the
3 pedigree papers as required in this paragraph. If the
4 manufacturer or repackager has uniquely serialized the
5 individual legend drug unit, that identifier must also be
6 included on the form approved by the department and is
7 required of any subsequent transfers of prescription drugs
8 received by a direct purchase wholesaler in a transaction
9 governed by this paragraph. The pedigree paper must also
10 include the name, address, telephone number, and, if
11 available, e-mail contact information of each wholesaler
12 involved in the chain of custody of the legend drug. The
13 department shall adopt rules and a form relating to the
14 requirements of this paragraph.
15 Section 2. Subsection (29) of section 499.005, Florida
16 Statutes, is amended to read:
17 499.005 Prohibited acts.--It is unlawful for a person
18 to perform or cause the performance of any of the following
19 acts in this state:
20 (29) The receipt of a prescription drug pursuant to a
21 wholesale distribution without either first receiving a
22 pedigree paper that was attested to as accurate and complete
23 by the wholesale distributor or complying with the provisions
24 of s. 499.0121(6)(f)6.
25 Section 3. Section 499.006, Florida Statutes, is
26 amended to read:
27 499.006 Adulterated drug or device.--A drug or device
28 is adulterated:
29 (1) If it consists in whole or in part of any filthy,
30 putrid, or decomposed substance;
31 (2) If it has been produced, prepared, packed, or held
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1 under conditions whereby it could have been contaminated with
2 filth or rendered injurious to health;
3 (3) If it is a drug and the methods used in, or the
4 facilities or controls used for, its manufacture, processing,
5 packing, or holding do not conform to, or are not operated or
6 administered in conformity with, current good manufacturing
7 practices to assure that the drug meets the requirements of
8 ss. 499.001-499.081 and that the drug has the identity and
9 strength, and meets the standard of quality and purity, which
10 it purports or is represented to possess;
11 (4) If it is a drug and its container is composed, in
12 whole or in part, of any poisonous or deleterious substance
13 which could render the contents injurious to health;
14 (5) If it is a drug and it bears or contains, for the
15 purpose of coloring only, a color additive that is unsafe
16 within the meaning of the federal act; or, if it is a color
17 additive, the intended use of which in or on drugs is for the
18 purpose of coloring only, and it is unsafe within the meaning
19 of the federal act;
20 (6) If it purports to be, or is represented as, a drug
21 the name of which is recognized in the official compendium,
22 and its strength differs from, or its quality or purity falls
23 below, the standard set forth in such compendium. The
24 determination as to strength, quality, or purity must be made
25 in accordance with the tests or methods of assay set forth in
26 such compendium, or, when such tests or methods of assay are
27 absent or inadequate, in accordance with those tests or
28 methods of assay prescribed under authority of the federal
29 act. A drug defined in the official compendium is not
30 adulterated under this subsection merely because it differs
31 from the standard of strength, quality, or purity set forth
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1 for that drug in such compendium if its difference in
2 strength, quality, or purity from such standard is plainly
3 stated on its label;
4 (7) If it is not subject to subsection (6) and its
5 strength differs from, or its purity or quality falls below
6 the standard of, that which it purports or is represented to
7 possess;
8 (8) If it is a drug:
9 (a) With which any substance has been mixed or packed
10 so as to reduce the quality or strength of the drug; or
11 (b) For which any substance has been substituted
12 wholly or in part;
13 (9) If it is a drug or device for which the expiration
14 date has passed; or
15 (10) If it is a legend drug for which the required
16 pedigree paper is nonexistent, fraudulent, or incomplete under
17 the requirements of ss. 499.001-499.081 or applicable rules,
18 or that has been purchased, held, sold, or distributed at any
19 time by a person not authorized under federal or state law to
20 do so; or.
21 (11) If it is a prescription drug subject to, defined
22 by, or described by s. 503(b) of the Federal Food, Drug, and
23 Cosmetic Act which has been returned by a veterinarian to a
24 limited prescription drug veterinary wholesaler.
25 Section 4. Subsection (1) and paragraph (d) of
26 subsection (2) of section 499.01, Florida Statutes, are
27 amended to read:
28 499.01 Permits; applications; renewal; general
29 requirements.--
30 (1) Prior to operating, a permit is required for each
31 person and establishment that intends to operate as:
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1 (a) A prescription drug manufacturer;
2 (b) A prescription drug repackager;
3 (c) An over-the-counter drug manufacturer;
4 (d) A compressed medical gas manufacturer;
5 (e) A device manufacturer;
6 (f) A cosmetic manufacturer;
7 (g) A prescription drug wholesaler;
8 (h) A veterinary prescription drug wholesaler;
9 (i) A compressed medical gas wholesaler;
10 (j) An out-of-state prescription drug wholesaler;
11 (k) A nonresident prescription drug manufacturer;
12 (l) A freight forwarder;
13 (m) A retail pharmacy drug wholesaler;
14 (n) A veterinary legend drug retail establishment;
15 (o) A medical oxygen retail establishment;
16 (p) A complimentary drug distributor; or
17 (q) A restricted prescription drug distributor; or.
18 (r) A limited prescription drug veterinary wholesaler.
19 (2)
20 (d) A permit for a prescription drug manufacturer,
21 prescription drug repackager, prescription drug wholesaler,
22 limited prescription drug veterinary wholesaler, or retail
23 pharmacy wholesaler may not be issued to the address of a
24 health care entity or to a pharmacy licensed under chapter
25 465, except as provided in this paragraph. The department may
26 issue a prescription drug manufacturer permit to an applicant
27 at the same address as a licensed nuclear pharmacy, which is a
28 health care entity, for the purpose of manufacturing
29 prescription drugs used in positron emission tomography or
30 other radiopharmaceuticals, as listed in a rule adopted by the
31 department pursuant to this paragraph. The purpose of this
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1 exemption is to assure availability of state-of-the-art
2 pharmaceuticals that would pose a significant danger to the
3 public health if manufactured at a separate establishment
4 address from the nuclear pharmacy from which the prescription
5 drugs are dispensed. The department may also issue a retail
6 pharmacy wholesaler permit to the address of a community
7 pharmacy licensed under chapter 465 which does not meet the
8 definition of a closed pharmacy in s. 499.003.
9 Section 5. Paragraph (g) of subsection (2) of section
10 499.012, Florida Statutes, is amended, and paragraph (h) is
11 added to that subsection, to read:
12 499.012 Wholesale distribution; definitions; permits;
13 applications; general requirements.--
14 (2) The following types of wholesaler permits are
15 established:
16 (g) A veterinary prescription drug wholesaler
17 permit.--A veterinary prescription drug wholesaler permit is
18 required for any person that engages in the distribution of
19 veterinary prescription drugs in or into this state. A
20 veterinary prescription drug wholesaler that also distributes
21 prescription drugs subject to, defined by, or described by s.
22 503(b) of the Federal Food, Drug, and Cosmetic Act which it
23 did not manufacture must obtain a permit as a prescription
24 drug wholesaler, an or out-of-state prescription drug
25 wholesaler, or a limited prescription drug veterinary
26 wholesaler in lieu of the veterinary prescription drug
27 wholesaler permit. A veterinary prescription drug wholesaler
28 must comply with the requirements for wholesale distributors
29 under s. 499.0121, except those set forth in s.
30 499.0121(6)(d), (e), or (f).
31 (h) Limited prescription drug veterinary wholesaler
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1 permit.--Unless engaging in the activities of and permitted as
2 a prescription drug manufacturer, nonresident prescription
3 drug manufacturer, prescription drug wholesaler, or
4 out-of-state prescription drug wholesaler, a limited
5 prescription drug veterinary wholesaler permit is required for
6 any person that engages in the distribution in or into this
7 state of veterinary prescription drugs and prescription drugs
8 subject to, defined by, or described by s. 503(b) of the
9 Federal Food, Drug, and Cosmetic Act to veterinarians under
10 the following conditions:
11 1. The person is engaged in the business of
12 wholesaling prescription and veterinary legend drugs to
13 persons:
14 a. Licensed as veterinarians practicing on a full-time
15 basis;
16 b. Regularly and lawfully engaged in instruction in
17 veterinary medicine;
18 c. Regularly and lawfully engaged in law enforcement;
19 d. For use in research, not involving clinical use; or
20 e. For use in chemical analysis or physical testing,
21 for the purposes of instruction in law enforcement, research,
22 or testing.
23 2. No more than 30 percent of prescription drug sales
24 may be prescription drugs approved for human use which are
25 subject to, defined by, or described by s. 503(b) of the
26 Federal Food, Drug, and Cosmetic Act.
27 3. The person is not permitted, licensed, or otherwise
28 authorized in any state to wholesale prescription drugs
29 subject to, defined by, or described by s. 503(b) of the
30 Federal Food, Drug, and Cosmetic Act to any person who is
31 authorized to sell, distribute, purchase, trade, or use these
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1 drugs on or for humans.
2 4. A limited prescription drug veterinary wholesaler
3 that applies to the department for a new permit or the renewal
4 of a permit must submit a bond of $20,000, or other equivalent
5 means of security acceptable to the department, such as an
6 irrevocable letter of credit or a deposit in a trust account
7 or financial institution, payable to the Florida Drug, Device,
8 and Cosmetic Trust Fund. The purpose of the bond is to secure
9 payment of any administrative penalties imposed by the
10 department and any fees and costs incurred by the department
11 regarding that permit which are authorized under state law and
12 which the permittee fails to pay 30 days after the fine or
13 costs become final. The department may make a claim against
14 such bond or security until 1 year after the permittee's
15 license ceases to be valid or until 60 days after any
16 administrative or legal proceeding authorized in ss.
17 499.001-499.081 which involves the permittee is concluded,
18 including any appeal, whichever occurs later.
19 5. A limited prescription drug veterinary wholesaler
20 must maintain at all times a license or permit to engage in
21 the wholesale distribution of prescription drugs in compliance
22 with laws of the state in which it is a resident.
23 6. A limited prescription drug veterinary wholesaler
24 must comply with the requirements for wholesale distributors
25 under s. 499.0121, except that a limited prescription drug
26 veterinary wholesaler is not required to provide a pedigree
27 paper as required by s. 499.0121(6)(f) upon the wholesale
28 distribution of a prescription drug to a veterinarian.
29 7. A limited prescription drug veterinary wholesaler
30 may not return to inventory for subsequent wholesale
31 distribution any prescription drug subject to, defined by, or
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1 described by s. 503(b) of the Federal Food, Drug, and Cosmetic
2 Act which has been returned by a veterinarian.
3 8. An out-of-state prescription drug wholesaler's
4 permit or a limited prescription drug veterinary wholesaler
5 permit is not required for an intracompany sale or transfer of
6 a prescription drug from an out-of-state establishment that is
7 duly licensed to engage in the wholesale distribution of
8 prescription drugs in its state of residence to a licensed
9 limited prescription drug veterinary wholesaler in this state
10 if both wholesalers conduct wholesale distributions of
11 prescription drugs under the same business name. The
12 recordkeeping requirements of s. 499.0121(6) must be followed
13 for this transaction.
14 Section 6. Paragraph (f) of subsection (6) of section
15 499.0121, Florida Statutes, is amended to read:
16 499.0121 Storage and handling of prescription drugs;
17 recordkeeping.--The department shall adopt rules to implement
18 this section as necessary to protect the public health,
19 safety, and welfare. Such rules shall include, but not be
20 limited to, requirements for the storage and handling of
21 prescription drugs and for the establishment and maintenance
22 of prescription drug distribution records.
23 (6) RECORDKEEPING.--The department shall adopt rules
24 that require keeping such records of prescription drugs as are
25 necessary for the protection of the public health.
26 (f)1. Effective July 1, 2006, each person who is
27 engaged in the wholesale distribution of a prescription drug
28 and who is not the manufacturer of that drug must, before each
29 wholesale distribution of such drug, provide to the person who
30 receives the drug a pedigree paper as defined in s.
31 499.003(31).
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1 2. A repackager must comply with this paragraph.
2 3. The pedigree paper requirements in this paragraph
3 do not apply to compressed medical gases or veterinary legend
4 drugs.
5 4. Each wholesale distributor of prescription drugs
6 must maintain separate and distinct from other required
7 records all statements that are required under subparagraph 1.
8 5. In order to verify compliance with subparagraph
9 (d)1., each manufacturer of a prescription drug sold in this
10 state must make available upon request distribution
11 documentation related to its sales of prescription drugs,
12 regardless of whether the prescription drug was sold directly
13 by the manufacturer to a person in Florida.
14 6. Subparagraph 1. does not apply to a wholesale
15 distributor that takes title to, but not possession of, a
16 prescription drug and the prescription drug's manufacturer
17 ships the prescription drug directly to a person authorized by
18 law to administer or dispense prescription drugs or a member
19 of an affiliated group, except a repackager, described in
20 paragraph (h).
21 a. The wholesale distributor must send an invoice to
22 the purchaser of the prescription drug that contains a clear
23 cross-reference to the shipping document sent by the
24 manufacturer to the purchaser of the prescription drug.
25 b. The purchaser of the prescription drug must obtain
26 a shipping document from the manufacturer that contains, at a
27 minimum:
28 (I) The name and address of the manufacturer,
29 including the point of origin of the shipment; the wholesaler;
30 and the purchaser.
31 (II) The name of the prescription drug as it appears
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1 on the label.
2 (III) The quantity, dosage form, and strength of the
3 prescription drug.
4 (IV) The date of the shipment.
5 c. The manufacturer must also make available to the
6 department, upon request, the lot number of the prescription
7 drug if the lot number is not contained in the shipping
8 document received by the purchaser.
9 7. The department may by rule define alternatives to
10 compliance with subparagraph 1. for a prescription drug in the
11 inventory of a permitted prescription drug wholesaler as of
12 June 30, 2006, and the return of a prescription drug purchased
13 prior to July 1, 2006. The department may specify time limits
14 for such alternatives.
15 Section 7. Paragraph (d) of subsection (1) of section
16 499.0122, Florida Statutes, is amended to read:
17 499.0122 Medical oxygen and veterinary legend drug
18 retail establishments; definitions, permits, general
19 requirements.--
20 (1) As used in this section, the term:
21 (d) "Veterinary legend drug retail establishment"
22 means a person permitted to sell veterinary legend drugs to
23 the public or to veterinarians, but does not include a
24 pharmacy licensed under chapter 465.
25 1. The sale to the public must be based on a valid
26 written order from a veterinarian licensed in this state who
27 has a valid client-veterinarian relationship with the
28 purchaser's animal.
29 2. Veterinary legend drugs may not be sold in excess
30 of the amount clearly indicated on the order or beyond the
31 date indicated on the order.
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1 3. An order may not be valid for more than 1 year.
2 4. A veterinary legend drug retail establishment may
3 not purchase, sell, trade, or possess human prescription drugs
4 or any controlled substance as defined in chapter 893.
5 5. A veterinary legend drug retail establishment must
6 sell a veterinary legend drug in the original, sealed
7 manufacturer's container with all labeling intact and legible.
8 The department may adopt by rule additional labeling
9 requirements for the sale of a veterinary legend drug.
10 Section 8. Paragraph (h) is added to subsection (2) of
11 section 499.041, Florida Statutes, to read:
12 499.041 Schedule of fees for drug, device, and
13 cosmetic applications and permits, product registrations, and
14 free-sale certificates.--
15 (2) The department shall assess an applicant that is
16 required to have a wholesaling permit an annual fee within the
17 ranges established in this section for the specific type of
18 wholesaling.
19 (h) The fee for a limited prescription drug veterinary
20 wholesaler's permit may not be less than $300 or more than
21 $500 annually.
22 Section 9. Subsections (1) and (3) of section 499.065,
23 Florida Statutes, are amended to read:
24 499.065 Imminent danger.--
25 (1) Notwithstanding s. 499.051, the department shall
26 inspect each prescription drug wholesale establishment,
27 prescription drug repackager establishment, veterinary
28 prescription drug wholesale establishment, limited
29 prescription drug veterinary wholesaler establishment, and
30 retail pharmacy drug wholesaler establishment that is required
31 to be permitted under this chapter as often as necessary to
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1 ensure compliance with applicable laws and rules. The
2 department shall have the right of entry and access to these
3 facilities at any reasonable time.
4 (3) The department may determine that a prescription
5 drug wholesale establishment, prescription drug repackager
6 establishment, veterinary prescription drug wholesale
7 establishment, limited prescription drug veterinary wholesaler
8 establishment, or retail pharmacy drug wholesaler
9 establishment that is required to be permitted under this
10 chapter is an imminent danger to the public health and shall
11 require its immediate closure if the establishment fails to
12 comply with applicable laws and rules and, because of the
13 failure, presents an imminent threat to the public's health,
14 safety, or welfare. Any establishment so deemed and closed
15 shall remain closed until allowed by the department or by
16 judicial order to reopen.
17
18 For purposes of this section, a refusal to allow entry to the
19 department for inspection at reasonable times, or a failure or
20 refusal to provide the department with required documentation
21 for purposes of inspection, constitutes an imminent danger to
22 the public health.
23 Section 10. Paragraph (e) of subsection (3) of section
24 499.0661, Florida Statutes, is amended to read:
25 499.0661 Cease and desist orders; removal of certain
26 persons.--
27 (3) REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.--
28 (e)1. The chief executive officer, designated
29 representative, or the person holding the equivalent office,
30 of a permittee shall promptly notify the department if she or
31 he has actual knowledge that any affiliated party is charged
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1 with a felony in a state or federal court.
2 2. Whenever any affiliated party is charged with a
3 felony in a state or federal court or with the equivalent of a
4 felony in the courts of any foreign country with which the
5 United States maintains diplomatic relations, and the charge
6 alleges violation of any law involving prescription drugs,
7 pharmaceuticals, fraud, theft, or moral turpitude, the
8 department may enter an emergency order suspending the
9 affiliated party or restricting or prohibiting participation
10 by the affiliated party in the affairs of the particular
11 permittee or of any other permittee upon service of the order
12 upon the permittee and the affiliated party charged. The order
13 must contain notice of opportunity for a hearing pursuant to
14 ss. 120.569 and 120.57, where the affiliated party may request
15 a postsuspension hearing to show that continued service to or
16 participation in the affairs of the permittee does not pose a
17 threat to the public health or the interests of the permittee
18 and does not threaten to impair public confidence in the
19 permittee. In accordance with applicable departmental rules,
20 the department shall notify the affiliated party whether the
21 order suspending or prohibiting the person from participation
22 in the affairs of a permittee will be rescinded or otherwise
23 modified. The emergency order remains in effect, unless
24 otherwise modified by the department, until the criminal
25 charge is disposed of. The acquittal of the person charged, or
26 the final, unappealed dismissal of all charges against the
27 person, dissolves the emergency order but does not prohibit
28 the department from instituting proceedings under paragraph
29 (a). If the person charged is convicted or pleads guilty or
30 nolo contendere, whether or not an adjudication of guilt is
31 entered by the court, the emergency order shall become final.
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1 3. Whenever a permittee is charged with violation of
2 s. 499.0051 or s. 499.0052, the department may enter an
3 emergency order suspending the permittee's permit. The order
4 must contain notice of opportunity for a hearing pursuant to
5 ss. 120.569 and 120.57, where a permittee may request a
6 postsuspension hearing to show that continued operation by the
7 permittee under his or her permit does not pose a threat to
8 the public health and does not threaten to impair public
9 confidence in the permittee. In accordance with applicable
10 departmental rules, the department shall notify the permittee
11 whether the order suspending the permit of the permittee will
12 be rescinded or otherwise modified. The emergency order
13 remains in effect, unless otherwise modified by the
14 department, until the criminal charge is disposed of. The
15 acquittal of the permittee charged, or the final, unappealed
16 dismissal of all charges against the permittee, dissolves the
17 emergency order but does not prohibit the department from
18 instituting proceedings under paragraph (a). If a permittee
19 charged with a violation of s. 499.0051 or s. 499.0052 is
20 convicted or pleads guilty or nolo contendere, whether or not
21 an adjudication of guilt is entered by the court, the
22 emergency order shall become final.
23 4. The department shall publish on its website a list
24 of all permittees against whom an emergency order or a
25 permanent order under this section is entered.
26 Section 11. Subsections (8) and (9) are added to
27 section 499.067, Florida Statutes, to read:
28 499.067 Denial, suspension, or revocation of permit,
29 certification, or registration.--
30 (8) The department shall deny an application for a
31 permit for an establishment if the applicant, any person named
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1 pursuant to s. 499.012(3)(k) in the applicant's application,
2 or the person designated pursuant to s. 499.012(11) by the
3 applicant has been convicted or pleaded guilty or nolo
4 contendere to a violation of s. 499.0051 or s. 499.0052,
5 whether or not an adjudication of guilt is entered by the
6 court.
7 (9) The department shall revoke the permit of an
8 establishment if the permittee, any person named pursuant to
9 s. 499.012(3)(k) in the permittee's application, or the person
10 designated pursuant to s. 499.012(11) by the permittee has
11 been convicted or pleaded guilty or nolo contendere to a
12 violation of s. 499.0051 or s. 499.0052, whether or not an
13 adjudication of guilt is entered by the court.
14 Section 12. This act shall take effect July 1, 2006.
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18 And the title is amended as follows:
19 Delete everything before the enacting clause
20
21 and insert:
22 A bill to be entitled
23 An act relating to drug distribution; amending
24 s. 499.003, F.S.; amending a definition;
25 requiring the Department of Health to approve a
26 document or electronic form relating to
27 pedigree papers; providing requirements for
28 pedigree papers that record certain
29 distributions of legend drugs; amending s.
30 499.005, F.S.; revising a prohibition relating
31 to pedigree papers; amending s. 499.006, F.S.;
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Florida Senate - 2006 COMMITTEE AMENDMENT
Bill No. CS for SB 926
Barcode 341664
1 providing that a drug is adulterated if it is a
2 certain prescription drug that has been
3 returned by a veterinarian to a limited
4 prescription drug veterinary wholesaler;
5 amending s. 499.01, F.S.; requiring a limited
6 prescription drug veterinary wholesaler to
7 obtain a permit for operation from the
8 Department of Health; providing that a permit
9 for a limited prescription drug veterinary
10 wholesaler may not be issued to the address of
11 certain health care entities; amending s.
12 499.012, F.S.; revising permit requirements for
13 a veterinary prescription drug wholesaler that
14 distributes prescription drugs; establishing a
15 permit for a limited prescription drug
16 veterinary wholesaler; providing requirements;
17 providing an exception; amending s. 499.0121,
18 F.S.; requiring certain wholesale distributors
19 taking title to a prescription drug to provide
20 an invoice to the purchaser containing certain
21 information; requiring a purchaser of a
22 prescription drug to obtain from the
23 manufacturer a shipping document containing
24 specified information; requiring a manufacturer
25 to make certain information available to the
26 department; authorizing the department to adopt
27 certain rules relating to the inventory and
28 return of certain prescription drugs; amending
29 s. 499.0122, F.S.; redefining the term
30 "veterinary legend drug retail establishment";
31 amending s. 499.041, F.S.; requiring the
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Florida Senate - 2006 COMMITTEE AMENDMENT
Bill No. CS for SB 926
Barcode 341664
1 department to assess an annual fee within a
2 certain monetary range for a limited
3 prescription drug veterinary wholesaler permit;
4 amending s. 499.065, F.S.; requiring the
5 department to inspect each limited prescription
6 drug veterinary wholesaler establishment;
7 authorizing the department to determine that a
8 limited prescription drug veterinary wholesaler
9 establishment is an imminent danger to the
10 public; amending s. 499.0661, F.S.; providing
11 for emergency suspension of a permittee if
12 charged with specified violations; requiring
13 the department to publish a list of certain
14 permittee names; amending s. 499.067, F.S.;
15 prohibiting issuance of permits to specified
16 applicants; requiring revocation of permits of
17 specified permittees; providing an effective
18 date.
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